SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN) is advancing towards the final stages of Good Manufacturing Practice (GMP) production and formulation for its lead drug candidate, ONP-002, in preparation for an anticipated Phase IIA clinical trial. The company is targeting the treatment of mild traumatic brain injury, commonly known as concussion, with a novel intranasal delivery system.
The drug candidate, ONP-002, is a new chemical entity designed for self-propelled powdered delivery directly to the brain via the nasal cavity. A completed 40-patient Phase I human study indicated that ONP-002 was safe and well-tolerated.
Oragenics is currently manufacturing the Active Pharmaceutical Ingredient (API), which will then be formulated into a nanoparticle powder and loaded into a unique, breath-propelled intranasal device. This device is intended to enhance the drug's binding to the olfactory nerve beds, thereby facilitating direct brain delivery.
Oragenics aims to make this treatment available for use in the field, especially in the critical early stages following a concussion. The upcoming Phase II trial plans to recruit patients aged 18-55 who are in the acute phase post-concussion.
Animal studies have shown that intranasal delivery of ONP-002 as a nanoparticle can increase brain exposure and metabolism. This method has also demonstrated improved outcomes and safety following concussion in preclinical trials. "We are excited to be finishing up ONP-002 manufacturing and formulation work needed for our Phase II study which is on the horizon," commented Michael Redmond, President of Oragenics.
Concussions, which are estimated at 69 million cases annually worldwide, can result from falls, vehicle accidents, and contact sports. They are linked to a range of neurological disorders and can lead to long-term disability in up to 20% of affected patients. "Manufacturing and formulating API in a GMP facility ensures the integrity of the drug before and during the trials," stated Greg Gironda, Oragenics Operational Consultant.
This news is based on a press release statement and contains forward-looking statements, including Oragenics' plans and expectations regarding the Phase II clinical trial for ONP-002. These statements are subject to risks and uncertainties, and actual results may differ. The company does not assume any obligation to update these forward-looking statements, except as required by law.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.